The
PHSS have produced a comprehensive monograph on bio-contamination in
pharmaceutical and healthcare environments. The monograph examines
bio-contamination characterisation, environmental control, environmental
monitoring, deviations, and practices in GMP and classified areas.
The
contents are:
Section
1. Introduction and scope includes a review of the challenges and requirements
for Bio-contamination control and cross contamination control with a holistic
approach to monitoring and proactive investigations in response to increased
risk from changes in biocontamination profiles.
Section
2. Bio-contamination characterisation and risk profiling. Methodologies and
strategies that profile bio-contamination through establishing control, in
operations and holistic monitoring.
Section
3. Bio-contamination control principles and best practice guidance considering
Quality by Design, different processes, control attributes, background
environments and Barrier technologies.
Section
4. Bio-contamination monitoring including classical and Rapid Micro Methods
(RMM).
Section
5. Bio-contamination Deviation management including considerations and guidance
in completing investigations and undertaking corrective and preventative
actions (CAPA).
The
document was developed by James Drinkwater, Andrew Hopkins, Mike Davies, Ian
Symonds, Tim Sandle, Tim Eaton, Una Hearty, Jim Filer, Malcolm Homes and Tim
Triggs. Peer review was undertaken by a number of industry experts. The review
included the U.K. regulatory inspection agency, the MHRA.
The
document is reference is:
PHSS
(2014) Bio-contamination, Technical Monograph No. 20, Pharmaceutical and
Healthcare Sciences Society, Wiltshire, U.K.
Posted by Tim Sandle
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